MAUDE Adverse Event Report: CHAMPION MANUFACTURING INC MECHANICAL CHAIR/TRANSPORT CHAIR; MEDICAL CHAIR AND TABLE

Model Number UNKNOWN

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Hip Fracture (2349)

Event Type  Injury  

Manufacturer Narrative

Assuming this is a champion chair (which could not be verified), it has been determined this is an operational issue.Review of operator manual provides proper operation of foot tray and warnings on page 14.Review of the history of this facility shows they have purchased over 100 chairs on a periodic basis from champion from 2004 through 2017.Review of service parts and sales activity over that timeframe shows no repairs done to their chairs or mechanical parts purchased that would pertain to any foot trays.Facility ordered (140) sets of 3" casters june 4, 2018.

Event Description

On 4/6/2018 phone call from facility was to order replacement parts.The facility wanted to order optional smaller casters.There was no complaint stated, but it was mentioned that the facility decided to remove the foot trays due to patient falls and now the chairs are too high for many patients.Facility was made aware of the optional yellow foot tray and with a caution label in english, french and spanish for higher visibility, they declined that option.Caution label states: caution weight capacity 225 lbs.Stow when not in use with staff assistance only.On 5/31/2018 phone call advised that sometime near the beginning of the year (2018) a visitor tripped over a foot tray that was left extended on a chair.The facility was unsure if the visitor was sitting in the chair or just walking by the chair.The visitor fell and fractured a hip, which required surgery to repair.On 6/15/2018 phone call produced the information regarding the individual involved and that no serial number was recorded for this incident, no date or time of incident was reported.It is assumed this is a champion product but that cannot be verified.

• Brand Name: MECHANICAL CHAIR/TRANSPORT CHAIR
• Type of Device: MEDICAL CHAIR AND TABLE
• Manufacturer (Section D): CHAMPION MANUFACTURING INC; 2601 industrial parkway; elkhart IN 46516
• Manufacturer (Section G): CHAMPION MANUFACTURING INC; 2601 industrial parkway; elkhart IN 46516
• Manufacturer Contact: christine miller ; 2601 industrial parkway; elkhart, IN 46516 ; 8009985018
• MDR Report Key: 7722743
• MDR Text Key: 115125444
• Report Number: 1834066-2018-00002
• Device Sequence Number: 1
• Product Code: KMN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA - CLASS I
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 64